The GLG (Gastric Light Guide) is a multi-channel bougie which allows all functions to be performed with one device and one insertion. The GLG is a single use device that is provided sterile (sterilized using Ethylene Oxide). A light channel runs the full length of the bougie, illuminating the oral cavity and pharynx for proper insertion. The GLG connects to a battery powered light handle that are 510(k) exempt under product codes FSW and HJM. The GLG transilluminates the anterior stomach wall while suction holds it in place, highlighting the shape of the bougie and allowing the surgeon to see the best path for stapling. The GLG is inserted at the beginning of the procedure and not removed until after the leak test. The GLG is composed of a double lumen tube composed of medical grade PVC with holes and an atraumatic tip. There is a blue connector for use with standard suction equipment 36 Fr. The light wire is a 3mm diameter wire composed of PMMA with several cut-outs. The light wire does not make patient contact. There is a black connector 10 Fr for the light wire to be connected to a reusable light handle, battery operated LED light source. There is only one model available GLG001, size 36 Fr and 1000mm in length with a closed lightwire channel. The GLG devices are packaged in paper/film packages of material suitable for ethylene oxide sterilization. The units are sold in carton boxes which contain 6 intermediate boxes of 5 units of GLG each.

AI/ML Overview

The medical device in question is the Nasmed Gastric Lightguide (GLG). The provided text describes the acceptance criteria and the studies conducted to demonstrate its performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied by Standard/Purpose)	Reported Device Performance
Biocompatibility
Blood Interactions	No hemolytic activity (per ISO 10993-4)	Device does not exhibit hemolytic activity.
Cytotoxicity	Acceptable cytotoxicity rating (per ISO 10993-5)	Device has a rating of "1" (slight reactivity).
Intradermal Reactivity	No intradermal reactivity (per ISO 10993-10)	Device does not show any intradermal reactivity.
Irritation & Sensitizing Effect	No skin sensitization (per ISO 10993-10)	Device does not show any skin sensitization.
Acute Systemic Toxicity	No increased toxic effects (per ISO 10993-11)	Device does not show increased toxic effects.
Sterilization & Shelf Life
Ethylene Oxide Residuals	EO residuals meet requirements (per ISO 10993-7)	EO residuals met requirements (less than 0.05 mg/instrument in one study and less than 0.9888 mg/instrument in another study).
Sterilization Validation	Sterility Assurance Level (SAL) of 10^-6 (per ISO 11135-1:2014)	EO cycles produce medical devices with an SAL of 10^-6.
Aging Study	Support for 5-year shelf life, including chemical stability, packaging integrity, and sterility, with stable light wire functionality (per ISO 11607-1, ISO 11607-2, ASTM F88)	Real-time aging study supports 5-year shelf life, including chemical stability (alkalinity, acidity, reductive compounds), packaging integrity (intact seals, water permeability, seal strength, visual and dimensional), and sterility. Accelerated aging study verified light wire stability (no change to structure, flexibility, light intensity, or color).
Physical Performance
Tightness & Strength of Connector and Drain Connection	Catheter can withstand weights for 60 seconds and no air bubbles visible (per EN 1618:1997)	Catheter can within 60 seconds with weights attached to it and there were no air bubbles visible during testing.
Heat Emission Testing	Distal and proximal ends of lightwire do not get hot or produce a temperature that would cause burn injuries. External device temperature remains safe.	Study #1: Max temperature 24.5°C (distal tip) and 29.5°C (proximal tip) using standard xenon light source at max setting. Study #2: Max temperature 22.0°C (4 hours, portable light source) and 21.5°C (5 hours, stationary light source). Both considered safe and not causing burn injuries.
Design Verification	Dimensions, strength, tightness of joints, and gravitational flow meet specifications.	Dimensions, strength and tightness of joints and gravitational flow were verified during design verification. (Specific performance metrics are not given, but "verified" implies meeting predefined acceptance criteria).
Kinking Resistance	(Reference to EN 13868 implies a kinking test methodology was used and passed, but no specific criteria or results are given)	EN 13868 was used as a reference to test methodology. (Implied successful testing, but no specific performance data provided beyond methodology reference).
Catheter Common Properties	(Reference to EN 1618 implies that common properties were tested according to this standard, and passed)	EN 1618 was used as a reference to method methodology. (Implied successful testing, but no specific performance data provided beyond methodology reference).
Clinical Performance	No safety issues or complications, successful usage in intended procedures.	No safety issues or complications in 112 sleeve gastrectomy surgeries. Successful usage demonstrated.

2. Sample size used for the test set and the data provenance

Non-Clinical Performance Testing (Biocompatibility, Sterilization, Physical Performance, Aging): The document does not specify a distinct "test set" sample size for each performance test in the same way clinical studies do. Instead, standard laboratory testing methodologies are typically applied to representative samples of the device until acceptance criteria are met. For example, for Ethylene Oxide Residuals, two studies are mentioned, and for aging, both real-time and accelerated studies were performed. The specific number of devices tested for each non-clinical performance test is not explicitly stated.
Clinical Performance (Usability Study):
- Sample Size: 112 surgeries.
- Data Provenance: The study was conducted by Dr. Naser in Poland. This indicates it was a prospective clinical study in an international setting (Poland).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Non-Clinical Testing: For laboratory tests, subject matter experts in the respective fields (e.g., toxicology, microbiology, materials science) conduct the testing and interpret results against established standards. The specific number and qualifications of these experts are not detailed in the summary document.
Clinical Performance (Usability Study): The clinical study involved surgeries performed by "Dr. Naser". While this implies a qualified surgeon, the number of experts (surgeons) involved in establishing the "ground truth" (i.e., safety and successful usage) is implied to be at least one (Dr. Naser), and potentially more if a team was involved in observation/data collection. Their specific qualifications (e.g., years of experience in bariatric surgery) are not explicitly stated beyond being a doctor conducting the surgeries.

4. Adjudication method for the test set

Non-Clinical Testing: No formal adjudication method is typically described for standard lab tests. Results are generally objective measurements against pre-defined acceptance criteria from standards. Any deviations or ambiguities would be handled through internal quality processes.
Clinical Performance (Usability Study): For the clinical usability study, the phrase "There were no safety issues or complications" suggests direct observation and reporting by the clinician (Dr. Naser) or their team during and after the 112 surgeries. There is no mention of an independent adjudication committee or blinded review process for safety outcomes, implying a direct assessment by the surgical team.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a surgical instrument (gastric bougie with a lightguide), not an AI/imaging diagnostic tool that involves "human readers" or AI assistance in interpretation. The safety and effectiveness are assessed based on its physical properties, biocompatibility, sterilization, and clinical usability in surgery, not on diagnostic reading performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical surgical instrument and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Non-Clinical Testing: The ground truth for these tests is based on adherence to established international and national standards (e.g., ISO, EN, ASTM), which themselves represent a form of expert consensus and validated methodologies for assessing device properties.
Clinical Performance (Usability Study): The ground truth for the clinical study was based on observational outcomes data directly gathered during and after the 112 surgeries (e.g., absence of safety issues or complications). This is a direct measure of the device's performance in its intended clinical setting.

8. The sample size for the training set

Not applicable as this is a physical medical device, not an AI or machine learning model that requires a "training set."

9. How the ground truth for the training set was established

Not applicable as this is a physical medical device, not an AI or machine learning model.

Summary

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July 26, 2022

Nasmed % Joseph Azary Advisor / Consultant Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, CT 06484

K212407 Re:

Trade/Device Name: Gastric Lightguide (GLG) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: December 22, 2021 Received: December 23, 2021

Dear Joseph Azary:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

April Marrone, Ph.D., MBA Assistant Director (acting) DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212407

Device Name Gastric Lightguide (GLG)

Indications for Use (Describe)

Use in gastric and bariatric surgical procedures for the application of suction, stomach decompression and drainage of gastric fluids and irrigation.

Patient Population: For use in Adults only

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Nasmed Gastric Lightguide (GLG)

Sponsor:

Nasmed Ul Jana Nowaka Jezioranskiego 7/184 03-984 Warszawa Poland

Regulatory Correspondent for 510(k):

Joseph Azary Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, CT 06484 Phone: 203-242-6670

Date Updated: July 22, 2022

Name of Device: Gastric Light Guide (GLG)

Common or Usual Name: Gastrointestinal tube and accessories

Classification Name: Gastrointestinal tube and accessories

Regulatory Class: Class II, 21 CFR 876.

Product Code: KNT

Predicate Device:

Primary Predicate: K130483, ViSiGi 3D

Reference Device:

Reference Device: K964561, Transillumination Lighted Bougie System

Device Description

A light channel runs the full length of the bougie, illuminating the oral cavity and pharynx for proper insertion. The GLG connects to a battery powered light handle that are 510(k) exempt under product codes FSW and HJM.

The GLG transilluminates the anterior stomach wall while suction holds it in place, highlighting the shape of the bougie and allowing the surgeon to see the best path for stapling.

The GLG is inserted at the beginning of the procedure and not removed until after the leak test.

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The GLG is composed of a double lumen tube composed of medical grade PVC with holes and an atraumatic tip.

There is a blue connector for use with standard suction equipment 36 Fr.

The light wire is a 3mm diameter wire composed of PMMA with several cut-outs. The light wire does not make patient contact.

There is a black connector 10 Fr for the light wire to be connected to a reusable light handle, battery operated LED light source.

There is only one model available GLG001, size 36 Fr and 1000mm in length with a closed lightwire channel.

The GLG devices are packaged in paper/film packages of material suitable for ethylene oxide sterilization. The units are sold in carton boxes which contain 6 intermediate boxes of 5 units of GLG each.

Intended Use / Indications for Use

Use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids and irrigation.

Summary of Technological Characteristics

The subject device is The GLG (Gastric Light Guide) is a multi-channel bougie which allows all functions to be performed with one device and one insertion. The GLG is a single use device that is provided sterile (sterilized using Ethylene Oxide) validated per ISO 11135-1 affording a Sterility Assurance Level of 10-6.

The GLG transilluminates the anterior stomach wall while suction holds it in place, highlighting the shape of the bougie and allowing the surgeon to see the best path for stapling.

The GLG is inserted at the beginning of the procedure and not removed until after the leak test.

The GLG is composed of a double lumen tube composed of medical grade PVC with holes and an atraumatic tip.

There is a blue connector for use with standard suction equipment 36 Fr.

The light wire is a 3mm diameter wire composed of PMMA with several cut-outs. The light wire does not make patient contact.

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There is a black connector 10 Fr for the light wire to be connected to a reusable light handle, battery operated LED light source.

There is only one model available GLG001, size 36 Fr and 1000mm in length with a closed lightwire channel.

Substantial Equivalence Comparison

The GLG Gastric Light Guide is substantially equivalent to other legally marketed class II medical devices under Product Codes KNT. Specifically, the subject device is substantially equivalent to the ViSiGi 3D (K130483).

The GLG has the identical indications for use as the ViSiGi 3D exception for "serve as a sizing guide". The GLG is not used as a sizing guide.

Both the GLG and ViSiGi 3D are available in size 36 Fr and are of similar lengths (100cm compared to 107cm).

The main differences between the GLG and ViSiGi 3D are:

The subject device has a second lumen with a lightwire for illumination. -
The subject device is provided sterile whereas the ViSiGi 3D is provided non-sterile. Both । devices are for single patient usage.
-The subject device is composed of PVC as opposed to predicate is composed of thermoplastic Elastomer (Styrene-Ethylene – Butylene – Styrene) tube with LDPE valve connector.

The Innervision transillumination light bougie system (K964561) is also being included as a reference device for the illumination function. The transillumination system is available in 40 Fr, 50 Fr, and 56 Fr and can be connected to a commercially available light source. The GLG can also be connected to a commercially available light source.

This difference does not raise different questions of safety or efficacy. The GLG is as safe and effective as its predicate device.

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Performance Data

The subject device has been subjected to and passed the testing outlined in the non-clinical performance testing table.

	Non-Clinical Performance Testing Table
--	----------------------------------------	--	--

Test	Standard	Comments
Blood Interactions	ISO 10993-4	The testing concluded that the device does not exhibit hemolytic activity.
Cytotoxicity	ISO 10993-5	The testing concluded that the device has a rating of "1", which is slight reactivity.
IntradermalReactivity	ISO 10993-10	The testing concluded that the device does not show any intradermal reactivity.
Irritation andSensitizing Effect	ISO 10993-10	The testing concluded that the device does not show any skin sensitization.
Acute SystemicToxicity	ISO 10993-11	The testing concluded that the device does not show increased toxic effects.
Ethylene OxideResiduals	ISO 10993-7	The testing concluded that the EO residuals met requirements in ISO 10993-7. (less than 0.05 mg/instrument in one study and less than 0.9888 mg/instrument in another study).
SterilizationValidation	ISO 11135-1:2014	The validation confirmed that the EO cycles utilized for sterilization produce medical devices with a Sterility Assurance Level of $10^{-6}$ .
Tightness andStrength ofConnector andDrain Connection	EN 1618:1997	The testing confirmed that catheter can within 60 seconds with weights attached to it and that there were no air bubbles visible during testing.
Heat EmissionTesting	N/A	Study #1 The testing confirmed that the proximal end and distal tip temperature of the lightwire does not get hot or produce a temperature that would cause burn injuries. The testing was performed using a standard xenon light source at maximum setting. The maximum temperature was 24.5C at distal tip and 29.5C at proximal tip.Study# 2 The testing was conducted using the external device temperature. The testing was extended to 5 hours to well exceed any usage of the device. The
		testing used both a portable batterypowered light source and a stationarylight source. The maximum temperaturewas 22.0C at 4 hours for portable lightsource and 21.5C at 5 hours forstationary light source.
Aging Study	ISO 11607-1ISO 11607-2ASTM F88	An aging study was conducted real timeto support 5 year shelf life. The testingincluded chemical stability (alkalinity,acidity, and reductive compounds).Packaging integrity testing includeverification of intact seals, waterpermeability, seal strength, visual anddimensional. Additionally sterility testingwas performed.Additional accelerated aging studyperformed to verify light wire stability thatthat no change to structure, flexibility, lightintensity or color.
Design Verificationincludingdimensional,strength andtightness of joints,gravitational flow	N/A	Dimensions, strength and tightness ofjoints and gravitational flow were verifiedduring design verification.
Catheter - TestMethods for Kinkingof Single LumenCatheters andMedical Tubing	EN 13868	Used as a reference to test methodology
Test methods forcommon propertiesfor catheters otherthan intravascularcatheters	EN 1618	Used as a reference to methodmethodology.

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Clinical Testing

The device was used in 112 surgeries of sleeve gastrectomy. All patients met the category of morbid obesity and ages 19 – 62 years. The study was conducted by Dr. Naser in Poland. There were no safety issues or complications.

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Conclusions

The Nasmed GLG is as safe and effective as the predicate and reference devices. The Nasmed GLG has similar indications for use (except not used for sizing). The device has the same principles of operation and technological characteristics, as the predicate devices. There are only minor differences that do not alter its therapeutic purpose or raise new issues of safety or effectiveness, and performance data demonstrate that the GLG is as safe and effective as the predicate device. The non-clinical testing performed demonstrate that the subject device is as safe and effective and performs at as safely and effectively as the predicate device. Furthermore the usability study demonstrates successful usage in 112 surgeries. Thus, the GLG is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.